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$ wa t e r ma r k -t e xt


$ wa t e r m

a r k -t e xt

CONDE-AGUDELO et al. Page 25

T A B L E 1

s i n c l u d e d

N o o f w o m e n w

i t h

C L < 2 5 m m ,

s i n g

l e t o n g e s t a t

i o n ,

a n d p r e v

i o u s

p r e t e r m

b i r t

h

g c o u n

t r i e s

P r i m a r y

t a r g e t p o p u

l a t i o n

I n c l u s i o n

/ e x c

l u s i o n c r

i t e r

i a

I n t e r v e n t

i o n g r o u p

C o n

t r o l g r o u p

G e s

t a t i o n a l

a g e a t

s c r e e n

i n g

( w e e

k s )

I n t e r v e n

t i o n

C o i n t e r v e n t

i o n s

P r i m a r y o u

t c o m e

e d w

i t h p l a c e b o

d o m , C

h i l e ,

e

W o m e n w i t h a s h o r t c e r v i x

I n c l u s i o n : w o m e n w i t h a s i n g l e t o n o r t w i n

p r e g n a n c y a n d a s o n o g r a p h i c c e r v i c a l l e n g t h

1 5 .

1 5

2 3

2 0 2 5

V a g i n a l p r o g e s t e r o n e

c a p s u l e ( 2 0 0 m g / d a y )

o r p l a c e b o f r o m 2 4 t o

3 3 6 / 7 w e e k s o f

g e s t a t i o n

N o

S p o n t a n e o u s p r e t e r m

b i r t h < 3 4 w e e k s

E x c l u s i o n : m a j o r f e t a l a b n o r m a l i t i e s , p a i n f u l

r e g u l a r u t e r i n e c o n t r a c t i o n s , a

h i s t o r y o f

r u p t u r e d

m e m b r a n e s , o r c e r v i c a l c e r c l a g e .

, S o u

t h

C z e c h

hi l e

, E l

W o m e n w

i t h a

h i s t o r y o f

s p o n t a n e o u s p r e t e r m b i r t h

I n c l u s i o n : w o m e n w

i t h a s i n g

l e t o n p r e g n a n c y ,

1 8 4 5 y e a r s o f a g e , a n d a h i s t o r y o f

s p o n t a n e o u s s i n g l e t o n p r e t e r m b i r t h a t b e t w e e n

2 0 a n d 3 5 w e e k s o f g e s t a t i o n i n t h e

i m m e d i a t e l y p r e c e d i n g p r e g n a n c y .

9

1 3

1 6 2

2

V a g

i n a l p r o g e s

t e r o n e

g e l ( 9 0 m g / d a y ) o r

p l a c e b o f r o m 1 8 2 2 t o

3 7 0 / 7 w e e k s o f

g e s t a t i o n , r u p t u r e o f

m e m b r a n e s o r p r e t e r m

d e l i v e r y , w

h i c h e v e r

o c c u r r e d f i r s t .

N o

P r e t e r m

b i r t h

< 3 2

w e e k s

E x c l u s i o n : p l a n n e d c e r v i c a l c e r c l a g e , h

i s t o r y

o f a d v e r s e r e a c t i o n t o p r o g e s t e r o n e , t r e a t m e n t

w i t h p r o g e s t e r o n e w i t h i n 4 w e e k s b e f o r e

e n r o l l m e n t , t r e a t m e n t f o r a s e i z u r e d i s o r d e r , a

p s y c h i a t r i c i l l n e s s o r c h r o n i c h y p e r t e n s i o n a t

t h e t i m e o f e n r o l m e n t , h i s t o r y o f a c u t e o r

c h r o n i c c o n g e s

t i v e

h e a r

t f a i

l u r e , r e n a l

f a i l u r e ,

u n c o n t r o l l e d d i a b e t e s m e l l i t u s , a c t i v e l i v e r

d i s o r d e r , H I V i n f e c t i o n w i t h a C D 4 c o u n t o f

< 3 5 0 c e l l s / m m

3 a n d r e q u i r i n g m u l t i p l e

a n t i v i r a l a g e n t s , p l a c e n t a p r e v i a

, h i s t o r y o r

s u s p i c i o n o f b r e a s t o r g e n i t a l t r a c t m a l i g n a n c y ,

h i s t o r y o r s u s p i c i o n o f t h r o m b o e m b o l i c

d i s e a s e , M l l e r i a n d u c t a n o m a l y , m a j o r f e t a l

a n o m a l y o r c h r o m o s o m a l d i s o r d e r , o

r

m u l t i f e t a l g e s t a t i o n .

W o m e n a t h i g h r i s k o f p r e t e r m

b i r t h

I n c l u s i o n : w o m e n w i t h a l e a s t o n e p r e v i o u s

s p o n t a n e o u s p r e t e r m b i r t h , u

t e r i n e

m a l f o r m a t i o n o r t w i n p r e g n a n c y .

3

3

2 0 2 4

V a g i n a l p r o g e s t e r o n e

s u p p o s i t o r y ( 1 0 0 m g /

d a y ) o r p l a c e b o f r o m

2 4 t o 3 4 w e e k s o f

g e s t a t i o n .

N o

P r e t e r m b i r t h < 3 7

w e e k s

E x c l u s i o n : i n - p l a c e o r p l a n n e

d c e r v

i c a l

c e r c l a g e

, o r s e r i o u s f e t a l a n o m a l i e s

, R e p u b

l i c o f

le , C

z e c h

d i a , I s r a e l ,

W o m e n w

i t h a s h o r

t c e r v i x

I n c l u s i o n : w o m e n w

i t h a s i n g

l e t o n p r e g n a n c y ,

t r a n s v a g i n a l s o n o g r a p h i c c e r v i c a l l e n g t h

4 8

4 4

1 9 2

3

V a g

i n a l p r o g e s

t e r o n e

g e l ( 9 0 m g / d a y ) o r

p l a c e b o f r o m 2 0 2 3 t o

E m e r g e n c y c e r v

i c a l

c e r c l a g e ( 4 i n v a g i n a l

p r o g e s t e r o n e g r o u p

P r e t e r m

b i r t h

< 3 3

w e e k s


26/29



$ wa t e r m

a r k -t e xt


N o o f w o m e n w

i t h

C L < 2 5 m m ,

s i n g


i o n ,

a n d p r e v

i o u s

p r e t e r m

b i r t

h

g c o u n

t r i e s

P r i m a r y

t a r g e t p o p u

l a t i o n

I n c l u s i o n

/ e x c

l u s i o n c r

i t e r

i a

I n t e r v e n t

i o n g r o u p

C o n

t r o l g r o u p

G e s

t a t i o n a l

a g e a t

s c r e e n

i n g

( w e e

k s )

I n t e r v e n

t i o n


i o n s

P r i m a r y o u

t c o m e

S o u t h A f r i c a ,

b e t w e e n

1 0 a n d 2 0 m m , a n d w i t h o u t s i g n s o r

s y m p t o m s o f p r e t e r m l a b o r .

3 6 6 / 7 w e e k s o f

g e s t a t i o n , r u p t u r e o f

m e m b r a n e s o r p r e t e r m

d e l i v e r y , w h i c h e v e r

o c c u r r e d f i r s t .

[ 8 . 3

% ] a n d 1 [ 2

. 3 % ] i n

p l a c e b o g r o u p )

E x c l u s i o n : p l a n n e d c e r c l a g e , a c u t e c e r v i c a l

d i l a t i o n

, a l l e r g i c r e a c t i o n t o p r o g e s t e r o n e ,

c u r r e n t o r r e c e n t p r o g e s

t o g e n

t r e a t m e n

t w i t h i n

t h e p r e v i o u s f o u r w e e k s

, c h r o n i c m e d i c a l

c o n d i t i o n s t h a t w o u l d i n t e r f e r e w i t h s t u d y

p a r t i c i p a t

i o n o r e v a l u a

t i o n o f

t h e

t r e a t m e n

t ,

m a j o r f e t a l a n o m a l y o r k n o w n c h r o m o s o m a l

a b n o r m a l i t y

, u t e r i n e a n a t o m i c m a l f o r m a t i o n ,

v a g i n a l

b l e e

d i n g , o r k n o w n o r s u s p e c

t e d

c l i n i c a l c h o r i o a m n i o n i t i s .

e r c l a g e


I n c l u s i o n : w o m e n w i t h a s i n g l e t o n o r m u l t i p l e

g e s t a t i o n a n d t r a n s v a g i n a l s o n o g r a p h i c d i l a t i o n

o f t h e i n t e r n a l o s w i t h e i t h e r m e m b r a n e

p r o l a p s e i n t o t h e e n d o c e r v i c a l c a n a l a t l e a s t

2 5 % o f t h e t o t a l c e r v i c a l l e n g t h b u t n o t b e y o n d

t h e e x t e r n a l o s o r a c e r v i c a l l e n g t h < 2 5 m m .

5 3

4 9

1 6 2 4

M c D o n a l d p r o c e d u r e

w i t h a s i n g l e s t i t c h o f

p e r m a n e n t

m o n o f i l a m e n t o r n o

c e r c l a g e

C l i n d a m y c i n a n d

i n d o m e t a c i n w h i c h w e r e

d i s c o n t i n u e d a t

a p p r o x i m a t e l y 2 4 h o u r s

a f t e r r a n d o m i z a t i o n

( b o t h g r o u p s ) . R e s c u e

c e r c l a g e ( b o t h g r o u p s )

G e s t a t i o n a l a g e a t

d e l i v e r y a n d n e o n a t a l

m o r b i d i t y

E x c l u s i o n : m e m b r a n e p r o l a p s e b e y o n d t h e

e x t e r n a l o s , a n y f e t a l l e t h a l c o n g e n i t a l o r

c h r o m o s o m a l a n o m a l y , a b r u p t i o n p l a c e n t a

,

u n e x p l a i n e d v a g i n a l b l e e d i n g ,

c h o r i o a m n i o n i t i s , p e r s i s t e n t u t e r i n e a c t i v i t y

w i t h c e r v i c a l c h a n g e , o r a n y o t h e r

c o n t r a i n d i c a t i o n t o a c e r c l a g e p r o c e d u r e .

n d s


I n c l u s i o n : w o m e n w i t h a s i n g l e t o n g e s t a t i o n ,

r i s k f a c t o r s a n d / o r s y m p t o m s o f c e r v i c a l

i n c o m p e t e n c e , a n d a c e r v i c a l l e n g t h < 2 5 m m .

1 4

1 2

1 4 2 3


w i t h b r a i d e d p o l y e s t e r

t h r e a d o r n o c e r c l a g e

A m o x i c i l l i n / c l a v u l a n i c

a c i d f o r 7 d a y s a n d b e d

r e s t ( b o t h g r o u p s ) ; t w o

1 0 0 m g s u p p o s i t o r i e s o f

i n d o m e t h a c i n ( c e r c l a g e

g r o u p ) . R

e s c u e c e r c l a g e

( n o c e r c l a g e g r o u p )


w e e k s

, a n d n e o n a t a l

m o r b i d i t y a n d

m o r t a l i t y

E x c l u s i o n : f e t a l c o n g e n i t a l / c h r o m o s o m a l

a n o m a l i e s , p r e t e r m r u p t u r e o f m e m b r a n e s ,

m e m

b r a n e s

b u l g i n g

i n t o t h e v a g i n a , o r

i n t r a u t e r i n e i n f e c t i o n .

d o m , B r a z i l ,

S l o v e n i a ,

le


I n c l u s i o n : w o m e n w i t h a s i n g l e t o n g e s t a t i o n

a n d c e r v i c a l l e n g t h 1 5 m m .

2 1

2 3

2 2 2 4

S h i r o d k a r s u t u r e w i t h

m e r s i l e n e t a p e o r n o

c e r c l a g e

P r o p h y l a c t i c

c o r t i c o s t e r o i d s f o r f e t a l

l u n g m a t u r a t i o n ( b o t h

g r o u p s

) ; s i n g

l e d o s e o

f

e r y t h r o m y c i n ( c e r c l a g e

g r o u p )


w e e k s

E x c l u s i o n : m a j o r

f e t a l a b n o r m a l

i t i e s , p a i n f u l

r e g u l a r u t e r i n e c o n t r a c t i o n s , h

i s t o r y o f

r u p t u r e d

m e m

b r a n e s a n

d c e r v

i c a l c e r c

l a g e

i n

s i t u

, a n d

d i l a t e d c e r v

i x d u r i n g

t r a n s v a g i n a

l

s o n o g r a p h y .


27/29



$ wa t e r m

a r k -t e xt


N o o f w o m e n w

i t h

C L < 2 5 m m ,

s i n g


i o n ,

a n d p r e v

i o u s

p r e t e r m

b i r t

h

g c o u n

t r i e s

P r i m a r y

t a r g e t p o p u

l a t i o n

I n c l u s i o n

/ e x c

l u s i o n c r

i t e r

i a

I n t e r v e n t

i o n g r o u p

C o n

t r o l g r o u p

G e s

t a t i o n a l

a g e a t

s c r e e n

i n g

( w e e

k s )

I n t e r v e n

t i o n


i o n s

P r i m a r y o u

t c o m e


I n c l u s i o n : w o m e n w i t h a s i n g l e t o n o r t w i n

g e s t a t i o n a n

d c e r v

i c a l

l e n g

t h < 2 5 m m o r

s i g n i f i c a n t f u n n e l i n g ( > 2 5 % ) .

1 4

1 7

1 4 2 3


w i t h m e r s i

l e n e

t a p e o r

n o c e r c l a g e

B e d r e s t ( b o t h g r o u p s )


w e e

k s

E x c l u s i o n : h i s t o r y - i n d i c a t e d p r o p h y l a c t i c

c e r c l a g e

, l a s t p r e g n a n c y d e l i v e r e d a t t e r m ,

m a j o r f e t a l a n o m a l y , t r i p l e t s o r h i g h e r o r d e r

p r e g n a n c y , p

r e v i o u s i n c l u s i o n i n a n o t h e r t r i a l ,

c u r r e n t d r u g a b u s e , o r r e g u l a r c o n t r a c t i o n s

l e a d i n g t o p r e t e r m l a b o r a f t e r i d e n t i f i c a t i o n o f

a b n o r m a l c e r v i x b y u l t r a s o n o g r a p h y

.

W o m e n w i t h a s h o r t c e r v i x ,

s i n g l e t o n g e s t a t i o n , a n d p r i o r

s p o n t a n e o u s p r e t e r m b i r t h

I n c l u s i o n : w o m e n w i t h a s i n g l e t o n g e s t a t i o n , a t

l e a s t 1 p r i o r s p o n t a n e o u s p r e t e r m b i r t h

b e t w e e n

1 7 a n d 3 3 w e e k s o f g e s t a t i o n , a n d

m i d t r i m e s

t e r c e r v i c a

l l e n g t

h < 2 5 m m .

1 4 8

1 5 3

1 6 2 2


w i t h n o n a b s o r b a b l e

s u t u r e ( b r a i d e d t a p e ) o r

n o c e r c

l a g e

1 7 - h y d r o x y p r o g e s t e r

o n e c a p r o a t e ( 4 7

[ 3 1 . 8 % ] i n c e r c l a g e

g r o u p a n

d 5 2 [ 3 4 . 0 ] i n

n o c e r c l a g e g r o u p ) ;

v a g i n a l p r o g e s t e r o n e ( 1

[ 0 . 7

% ] i n n o c e r c l a g e

g r o u p ) . R e s c u e c e r c l a g e

( n o c e r c l a g e g r o u p )


w e e k s

E x c l u s i o n : f e t a l a n o m a l y , p l a n n e d h i s t o r y -

i n d i c a t e d c e r c l a g e f o r a c l i n i c a l d i a g n o s i s o f

c e r v i c a l i n s u f f i c i e n c y , a n d c l i n i c a l l y

s i g n i f i c a n t m a t e r n a l / f e t a l c o m p l i c a t i o n s ( e g ,

f e t a l r e d c e

l l i s o i m m u n

i z a t

i o n ,

t r e a t e d c h r o n i c

h y p e r t e n s i o n , i n s u l i n - d e p e n d e n t d i a b e t e s ) a n d

c e r v i c a l i n s u f f i c i e n c y - i n d i c a t e d c e r c l a g e i n a

p r i o r p r e g n a n c y .


28/29



$ wa t e r m

a r k -t e xt


T A B L E 2

a r i s o n s

D i r e c

t c o m p a r i s o n s

I n d i r e c t c o m p a r i s o n

V a g

i n a l p r o g e s

t e r o n e v e r s u s p l a c e b o

C e r c l a g e v e r s u s n o c e r c l a g e

V a g

i n a l p r o g e s

t e r o n e v e r s u s

c e r c

l a g e

N o . o f

t r i a l s

I n t e r v e n

t i o n n /

N ( % )

C o n t r o l n /

N ( % )

R R ( 9 5 %

C I )

I 2 ( % )

N o . o

f t r i a l s

I n t e r v e n

t i o n n /

N ( % )

C o n

t r o l n /

N ( % )

R R ( 9 5 %

C I )

P v a

l u e a

R R ( 9 5 %

C I )

P v a

l u e b

4

9 / 7 5 ( 1 2 . 0 )

2 4 / 8 3 ( 2 8 . 9 )

0 . 4 7 ( 0

. 2 4 0 . 9 1 )

0

5

4 8 / 2 5 0 ( 1 9 . 2 )

7 5 / 2 5 4 ( 2 9 . 5 )

0 . 6 6 ( 0

. 4 8 0 . 9 1 )

> . 1

0

0 . 7 1 ( 0 . 3 4 1 . 4 9 )

0 . 8 8

ity / m o r t a l i t y

c

4

7 / 7 5 ( 9

. 3 )

2 0 / 8 3 ( 2 4 . 1 )

0 . 4 3 ( 0

. 2 0 0 . 9 4 )

0

5

3 9 / 2 5 0 ( 1 5 . 6 )

6 3 / 2 5 4 ( 2 4 . 8 )

0 . 6 4 ( 0

. 4 5 0 . 9 1 )

> . 1

0

0 . 6 7 ( 0 . 2 9 1 . 5 7 )

0 . 8 6

4

3 4 / 7 5 ( 4 5 . 3 )

4 6 / 8 3 ( 5 5 . 4 )

0 . 8 4 ( 0

. 6 1 1 . 1 4 )

0

5

1 0 5 / 2 5 0 ( 4 2 . 0 )

1 5 4 / 2 5 4 ( 6 0

. 6 )

0 . 7 0 ( 0

. 5 8 0 . 8 3 )

> . 1

0

1 . 2 0 ( 0 . 8 4 1 . 7 2 )

0 . 9 4

4

2 0 / 7 5 ( 2 6 . 7 )

3 5 / 8 3 ( 4 2 . 2 )

0 . 6 6 ( 0

. 4 2 1 . 0 4 )

0

5

7 1 / 2 5 0 ( 2 8 . 4 )

1 0 5 / 2 5 4 ( 4 1

. 3 )

0 . 7 0 ( 0

. 5 5 0 . 8 9 )

> . 1

0

0 . 9 4 ( 0 . 5 6 1 . 5 8 )

0 . 9 8

4

6 / 7 5 ( 8

. 0 )

1 4 / 8 3 ( 1 6 . 9 )

0 . 5 1 ( 0

. 2 2 1 . 1 8 )

0

5

3 2 / 2 5 0 ( 1 2 . 8 )

5 1 / 2 5 4 ( 2 0 . 1 )

0 . 6 4 ( 0

. 4 3 0 . 9 6 )

> . 1

0

0 . 8 0 ( 0 . 3 1 2 . 0 2 )

0 . 9 2

e

4

3 / 7 5 ( 4

. 0 )

1 2 / 8 3 ( 1 4 . 5 )

0 . 3 8 ( 0

. 1 3 1 . 0 7 )

7

4

1 3 / 2 0 7 ( 6

. 3 )

2 1 / 1 9 6 ( 1 0 . 7 )

0 . 6 1 ( 0

. 3 2 1 . 1 9 )

> . 1

0

0 . 6 2 ( 0 . 1 8 2 . 1 6 )

0 . 8 4

h e m o r r h a g e

4

1 / 7 5 ( 1

. 3 )

3 / 8 3

( 3 . 6

)

0 . 5 0 ( 0

. 0 8 2 . 9 6 )

8

4

0 / 2 0 7 ( 0

. 0 )

4 / 1 9 6 ( 2

. 0 )

0 . 2 8 ( 0

. 0 5 1 . 6 4 )

> . 1

0

1 . 7 9 ( 0 . 1 5 2 2

. 0 0 )

0 . 8 0

4

0 / 7 5 ( 0

. 0 )

1 / 8 3

( 1 . 2

)

0 . 4 7 ( 0

. 0 2 1 0

. 3 2 )

0

4

1 / 2 0 7 ( 0

. 5 )

2 / 1 9 6 ( 1

. 0 )

0 . 6 2 ( 0

. 0 8 4 . 6 7 )

> . 1

0

0 . 7 6 ( 0 . 0 2 3 1

. 4 9 )

0 . 9 0

4

0 / 7 5 ( 0

. 0 )

6 / 8 3

( 7 . 2

)

0 . 2 5 ( 0

. 0 5 1 . 3 7 )

0

4

8 / 2 0 7 ( 3

. 9 )

1 7 / 1 9 6 ( 8 . 7 )

0 . 4 7 ( 0

. 2 1 1 . 0 5 )

> . 1

0

0 . 5 3 ( 0 . 0 8 3 . 3 5 )

0 . 7 8

2

0 / 5 1 ( 0

. 0 )

1 / 4 7

( 2 . 1

)

0 . 3 1 ( 0

. 0 1 7 . 3 2 )

0

1

7 / 1 3 5 ( 5

. 2 )

6 / 1 2 7 ( 4

. 7 )

1 . 1 0 ( 0

. 3 8 3 . 1 8 )

> . 1 0

0 . 2 8 ( 0 . 0 1 9 . 0 1 )

0 . 5 8

ty d

4

3 / 7 5 ( 4

. 0 )

1 6 / 8 3 ( 1 9 . 3 )

0 . 2 9 ( 0

. 1 1 0 . 8 1 )

0

4

1 7 / 2 0 7 ( 8

. 2 )

2 8 / 1 9 6 ( 1 4 . 3 )

0 . 6 0 ( 0

. 3 4 1 . 0 6 )

> . 1 0

0 . 4 8 ( 0 . 1 5 1 . 5 3 )

0 . 7 5

4

5 / 7 5 ( 6

. 7 )

7 / 8 3

( 8 . 4

)

0 . 7 3 ( 0

. 2 5 2 . 1 0 )

0

5

2 2 / 2 5 0 ( 8

. 8 )

3 5 / 2 5 4 ( 1 3 . 8 )

0 . 6 5 ( 0

. 4 0 1 . 0 7 )

> . 1 0

1 . 1 2 ( 0 . 3 5 3 . 6 3 )

0 . 9 6

4

1 1 / 7 5 ( 1 4 . 7 )

3 3 / 8 3 ( 3 9 . 8 )

0 . 3 9 ( 0

. 2 1 0 . 7 1 )

0

4

5 7 / 2 0 7 ( 2 7 . 5 )

6 7 / 1 9 6 ( 3 4 . 2 )

0 . 6 3 ( 0

. 3 4 1 . 1 8 )

< . 1

0

0 . 6 2 ( 0 . 2 6 1 . 4 8 )

0 . 8 4

4

3 0 / 7 5 ( 4 0 . 0 )

4 2 / 8 3 ( 5 0 . 6 )

0 . 7 9 ( 0

. 5 5 1 . 1 3 )

0

5

8 6 / 2 5 0 ( 3 4 . 4 )

1 1 7 / 2 4 9 ( 4 7

. 0 )

0 . 6 5 ( 0

. 4 2 1 . 0 0 )

< . 1

0

1 . 2 2 ( 0 . 6 9 2 . 1 4 )

0 . 9 3

4

8 / 7 5 ( 1 0 . 7 )

1 8 / 8 3 ( 2 1 . 7 )

0 . 5 3 ( 0

. 2 6 1 . 1 1 )

0

5

4 2 / 2 5 0 ( 1 6 . 8 )

6 6 / 2 4 9 ( 2 6 . 5 )

0 . 6 4 ( 0

. 4 5 0 . 9 0 )

> . 1 0

0 . 8 3 ( 0 . 3 7 1 . 8 5 )

0 . 9 3

e o n a t a l i n t e n s i v e c a r e u n i t ; R R , r e l a t i v e r i s k

Q s t a t i s t i c s ( t e s t o f h e t e r o g e n e i t y )

in g e v e n t s : r e s p i r a t o r y d i s t r e s s s y n d r o m e , g r a d e I I I / I V i n t r a v e n t r i c u l a r h e m o r r h a g e , n e c r o t i z i n g e n t e r o c o l i t i s

, n e o n a t a l s e p s i s

, b r o n c h o p u l m o n a r y d y s p l a s i a , o r p e r i n a t a l d e a t h

in g e v e n t s : r e s p i r a t o r y d i s t r e s s s y n d r o m e , g r a d e I I I / I V i n t r a v e n t r i c u l a r h e m o r r h a g e , n e c r o t i z i n g e n t e r o c o l i t i s

, n e o n a t a l s e p s i s , o r b r o n c h o p u l m o n a r y d y s p l a s i a


29/29



$ wa t e r m

a r k -t e xt


T A B L E 3

S e n s i t i v i t y a n a l y s i s b y e x c l u d i n g w o m e n w h o r e c e i v e d p r o g e s t e r o n e i n t r i a l s e v a l u a t i n g c e r c l a g e a n d p a t i e n t s w h o u n d e r w e n t a c e r c l a g e i n t r i a l s

e v a l u a t i n g v a g i n a l p r o g e s t e r o n e

D i r e c

t c o m p a r i s o n s

I n d i r e c t c o m p a r i s o n

V a g

i n a l p r o g e s

t e r o n e v e r s u s p

l a c e

b o

C e r c l a g e v e r s u s n o c e r c

l a g e

V a g

i n a l p r o g e s

t e r o n e v e r s u s c e r c

l a g e

O u t c o m e

I n t e r v e n

t i o n n /

N ( % )

C o n

t r o l n /

N ( % )

R R ( 9 5 %

C I )

I n t e r v e n

t i o n

C o n

t r o l

n / N ( % )

C o n

t r o l n /

N ( % )

R R ( 9 5 %

C I )

R R ( 9 5 %

C I )

P v a

l u e a

P r e t e r m b i r t h < 3 2 w e e k s

8 / 7 1 ( 1 1 . 3 )

2 4 / 8 2 ( 2 9 . 3 )

0 . 4 4 ( 0

. 2 2 0 . 8 7 )

4 0 / 2 0 3 ( 1 9 . 7 )

6 4 / 2 0 1 ( 3 1 . 8 )

0 . 6 3 ( 0

. 4 5 0 . 8 8 )

0 . 7 0 ( 0

. 3 3 1 . 5 0 )

0 . 8 8


5 / 7 1 ( 7

. 0 )

1 4 / 8 2 ( 1 7 . 1 )

0 . 4 6 ( 0

. 1 9 1 . 1 1 )

2 8 / 2 0 3 ( 1 3 . 8 )

4 3 / 2 0 1 ( 2 1 . 4 )

0 . 6 5 ( 0

. 4 3 1 . 0 0 )

0 . 7 1 ( 0

. 2 7 1 . 8 8 )

0 . 8 8

P r e t e r m

b i r t h

< 3 5 w e e k s

1 7 / 7 1 ( 2 3 . 9 )

3 5 / 8 2 ( 4 2 . 7 )

0 . 5 9 ( 0

. 3 7 0 . 9 5 )

5 7 / 2 0 3 ( 2 8 . 1 )

8 5 / 2 0 1 ( 4 2 . 3 )

0 . 6 7 ( 0

. 5 1 0 . 8 8 )

0 . 8 8 ( 0

. 5 1 1 . 5 2 )

0 . 9 6


3 1 / 7 1 ( 4 3 . 7 )

4 6 / 8 2 ( 5 6 . 1 )

0 . 8 0 ( 0

. 5 8 1 . 1 0 )

8 2 / 2 0 3 ( 4 0 . 4 )

1 2 3 / 2 0 1 ( 6 1 . 2 )

0 . 6 7 ( 0

. 5 5 0 . 8 2 )

1 . 1 9 ( 0

. 8 2 1 . 7 4 )

0 . 9 4

P e r i n a t a l m o r t a l i t y

4 / 7 1 ( 5

. 6 )

7 / 8 2 ( 8

. 5 )

0 . 6 1 ( 0

. 2 0 1 . 9 1 )

1 9 / 2 0 3 ( 9

. 4 )

3 3 / 2 0 1 ( 1 6 . 4 )

0 . 5 8 ( 0

. 3 5 0 . 9 8 )

1 . 0 5 ( 0

. 3 0 3 . 6 4 )

0 . 9 8

C I , c o n f i d e n c e i n t e r v a l ; R R , r e l a t i v e r i s k

a P v a l u e f o r t h e t e s t o f a s s o c i a t i o n

Am J Obstet Gynecol . Author manuscript; available in PMC 2013 January 01.

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